Fresenius Kidney Care Winter Park

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 39943 Based on interview, and record review the dialysis center failed to ensure all patient treatment plans were stored in the Emergency Evacuation Box. Review of the emergency box revealed a book with the patient treatment plans. The book was missing 6 patients treatment plans. Findings: On 8/26/24 at approximately 2:00 PM while reviewing the contents of the emergency evacuation box, the book which contained the patient information and treatment plans was reviewed. Review of the treatment plans revealed they were printed on 6/28/24. The Clinical Manager said the book is updated every quarter. When asked how new patients are added she stated that when they get a new admission the information is added to the book. She reviewed the book and confirmed that the information and treatment plans for 6 residents was not included in the book. The missing information was for patients who were admitted from 6/26/24-8/16/24. The Guidelines for Emergency Preparedness, dated 7/03/23 read: The purpose of this policy is to provide guidelines for emergency preparedness of In-center and Home Therapies facilities to help protect patients and staff in emergency situations. The facility must develop a communication plan for all patients (in-center and home). This plan includes the following: The Emergency and Disaster Patient Contact Information Sheet. A current copy of the emergency lists must: Be kept locked in the emergency supply boxes, or cart.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 13640 Based on interview and a review of facility documentation, the facility failed to ensure that testing for total chlorine was performed in accordance with their expectation on frequency. Findings: A review of facility policy Carbon Filtration Monitoring for In-center Central Water Systems Policy revealed the following: The FKC (Fresenius Kidney Care) approved test method to verify total chlorine levels of water used for hemodialysis and their respective procedures is the RPC Ulta-Low Total Chlorine Test Strip. . . . Two trained staff members, one of whom must be a licensed RN, will perform and verify total chlorine testing. . . . When to test. . . Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours.” Thus, throughout the treatment day there must be total chlorine testing at least every four hours. A review of the total chlorine test log for 7/12/24 revealed that a carbon test took place at 8:17 AM. The next one took place at 2:30 PM. This was over five hours later. A review of the total chlorine test log for 8/20/24 revealed that a carbon test took place at 8:04 AM. The next one took place at 2:15 PM. This was just over six hours later. During an interview of the Biomedical Manager on 8/26/24 at approximately 1:30 PM, he confirmed the discrepancies as shown above. He stated that an audit took place in early August of 2024 and that the next one will take place in the first week or two in September of 2024. He stated that they had caught the 7/12/24 discrepancy and developed an action plan.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 13640 Based on observations and interview, the facility failed to ensure that the facility was equipped to provide a safe treatment environment with non-expired medications. Findings: During an observation in the medication storage area on 8/27/24 at approximately 10:09 AM, a drawer in the cabinet was examined. It had one previously opened multi-dose vial of Doxercalciferol injection 4 MG (milligrams) / 2 ML (milliliters). It did not have any mention on its label of when the vial had first been used. It had a manufacturer-created expiration date of “2025-09.” Further examination of the box which held the vial revealed the following manufacturer’s recommendation printed on it: “Discard vial 3 days after-opening.” Without the opening date, it was not possible to determine whether or not it had expired per the three day use limit as stated. A review of facility policy “Medication Preparation and Administration” revealed the following: “Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date.” During an interview with the Administrator on 8/27/24 at approximately 1:00 PM, she confirmed the policy had not been followed.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 39943 Based on observation, interview and record review, the dialysis facility failed to follow hemodialysis orders and failed to provide documentation for not following the prescribed blood flow rate and dialysis flow rate related to estimated dry weight for 4 of 9 patients reviewed for dialysis prescription, (#1, #3, #4 #6 ) Patient # 6 also had 4 treatments where his actual post dialysis weight was more than 1 kilogram less that his target weight. Findings: 1. Patient #1 was admitted to the dialysis center on 12/09/19 and required dialysis due to diabetes. His treatment orders dated 8/27/24, included an order for an estimated dry weight (EDW) of 117.5 kilograms(kg.), blood flow rate (BFR) 450, Dialysate flow rate (DFR) 800, treatment 3 times per week and each treatment to run over 4 hours. Review of treatment sheets from 7/27/24-8/26/24, indicated the patient exceeded his EDW, BFR, or DFR for 6 of 9 treatments. Treatment sheet dated 7/27/24, indicated the patient’s BFR was decreased to 400, 350 and again to 300 without reasons documented in the comment section. Post dialysis weight (wt.) to be 123.30 kg. Documentation found to include a discussion with the patient regarding the offering of an extra treatment, patent refused. Treatment sheet dated 7/29/24, indicated the patient’s post dialysis wt. to be 125.20 kg. Documentation found to include a discussion with the patient regarding an extra treatment, patient agreed to extra treatment. Treatment sheet dated 7/30/24, indicated patients BFR to be 400 during entire treatment. DFR at start of treatment was 500 with no documentation of dialysis rate after start of treatment. Patients post dialysis wt. 122.60. There was no documentation of indications for the DFR or EDW not being met. Treatment sheet dated 7/31/24, indicated patients post dialysis wt. 122.0 kg. patient arrived late and machine set at 3.5 hours instead of 4 hours. Treatment sheet dated 8/13/24, indicated post dialysis wt. to be 130.20 kg. Patient was in the hospital. and was offered extra treatment. Treatment sheet dated 8/20/24 indicated post dialysis wt. to be 133.00. Documentation indicated patient agreed to extend treatment time by 15 minutes, but treatment started at 7:15 and ended at 11:17 equaling 4 hours and 2 minutes. Treatment sheet dated 8/26/24 indicated post dialysis wt. 127.40 kg. There was no documentation regarding an extra treatment day. BFR increased to 475 without documenting reasons. 2. Resident #3 was admitted to the facility on 1/22/22 and required dialysis due to hypertension. Patient’s treatment orders dated 7/14/24, included an order for an estimated dry weight (EDW) of 48 kilograms(kg.), blood flow rate (BFR) 400, Dialysate flow rate (DFR)500, treatment 3 times per week and each treatment to run over 3 hours and 30 minutes. Review of treatment sheets from 6/24/24-7/31/24, indicated the patient exceeded his EDW, BFR, or DFR for 5 of 5 treatments. Treatment sheet dated 6/24/24, indicated a post dialysis wt. of 49.30 kg. There was no documentation indicating an increase in time for treatment or an extra treatment offered. Treatment sheets dated 7/15/24, 7/19/24, 7/26/24, and 7/31/24, indicated the BFR to be decreased without documentation explaining the reason for the decrease. 3. Patient #4 was admitted to the facility on 12/10/22 and required dialysis due to diabetes. His treatment orders dated 8/22/24, included an order for EDW of 136.5 Kg., treatment 3 times per week for 3 hours and 45 minutes. Treatment sheets reviewed for 8/03/24-8/20/24, indicated that for 5 of 6 treatments the patient exceeded his post dialysis wt. without documented explanation. Treatment sheet dated 8/03/24, indicated a post dialysis wt. of 137.75 with no documentation indicating an additional treatment or increased time offered. Treatment sheet dated 8/10/24, indicated a post dialysis wt. of 139.2 with no documentation indicating an additional treatment or increased time. Treatment sheet dated 8/13/24, indicated a post dialysis wt. of 139.2 with no documentation indicating an additional treatment or increased time. Treatment sheet dated 8/15/24, indicated a post dialysis wt. of 137.75 with no documentation indicating an additional treatment or increased time. Treatment sheet dated 8/20/24, indicated a post dialysis wt. of 138.8 with no documentation indicating an additional treatment or increased time. On 8/26/24 at 1:45, PM Patient Care Technician A stated if the post dialysis wt. is not met, we would educate the patient regarding fluid intake, diet, and sodium. If the dry wt. is not achieved by the 3rd treatment, and the patient does not have a heart condition we would offer extra time for treatment or offer an extra treatment and the physician should be made aware if the dry wt. is not being met. 13640 A review of the medical record for patient #6 was performed. Physician orders of 8/1/24 indicated that the patient had an estimated dry weight of 89 KG. A physician note of 8/6/24 read: “DW (dry weight) adjusted to 89.0 KG.” This reflected the preceding orders. A review of the Treatment Sheet for 8/8/24 revealed the patient had a pre-treatment weight of 89.40 KG. It indicated a post-treatment weight of 87.20 KG, which was a decrease of 2.20 KG. A review of the Treatment Sheet for 8/13/24 revealed that the patient had a pre-treatment weight of 91.80 KG. It indicated a post-treatment weight of 89.20 KG, which was a decrease of 2.60 KG. A review of the Treatment Sheet for 8/20/24 revealed that the patient had a pre-treatment weight of 90.30 KG. It indicated a post-treatment weight of 87.20 KG, which was a decrease of 3.10 KG. A review of the Treatment Sheet for 8/22/24 revealed that the patient had a pre-treatment weight of 88.30 KG. It indicated a post-treatment weight of 84.50 KG, which was a decrease of 3.80 KG. In the preceding hemodialysis treatment sessions, the ordered dry weight was not attained, in violation of the physician orders. A physician note of 8/22/24 read: “DW adjusted to 88 KG.” However, he did not translate this into an order. The physician ordered a change in the dry weight to 86 KG on 8/29/24. A review of facility policy Nursing Supervision and Delegation revealed the following: “Prior to discharge, the RN must review the treatment record to: Confirm patient is stable for discharge. . . . The record must be reviewed for: . . . Whether patient is achieving dry weight and identifying reason for patient not achieving dry weight. . . . Correct dialysate prescription was delivered.” Also: “Document all findings in the patient’s medical record.” There was no documentation in the treatment notes concerning the reasons for the patient failing to reach the ordered dry weight. During an interview of the Clinical Manager on 8/27/24 at approximately 1:50 PM, she confirmed the findings.”